Re: Docket No. FDA-2011-D Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications

Transcription

1 701 Pennsylvania Avenue, Ste. 800 Washington, DC Tel: Fax: October 19, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD Re: Docket No. FDA-2011-D Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications Dear Sir or Madam: I am writing this letter to present AdvaMed s response to the subject Notice. We appreciate this opportunity to comment on the FDA Draft Guidance: Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications. In this submission we will address, some general comments and in the attached table a few specific comments on various aspects of the document. AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit We believe that with this guidance FDA has taken an important first step along the road to regulation of an important new category of medical devices that will only grow as time passes. The Agency s approach is cautious yet positive, and we are comfortable that it will avoid the trap of overregulating these devices. Despite our general satisfaction with the guidance, we do have several observations and questions, both general and specific. To assist CDRH in addressing these areas, we have attached several sheets of specific comments. The line numbers in our comments refer to a line-numbered draft that we prepared to facilitate commenting. A copy of this is also attached. Bringing innovation to patient care worldwide

2 Docket No. FDA-2011-D-0530 October 19, 2011 Page 2 General Comments Many persons who will produce mobile apps that will qualify as medical devices will not be aware that they are producing a regulated product. Thus, they are unlikely to read or to understand a standard FDA guidance, as it uses the terms and professional jargon common to the field. Thus, we recommend that FDA follow one of these two paths: 1. Revise the current document with whatever revisions seem appropriate based on comments received using more common plain language; 2. Complete the document in its current form and prepare a similar companion document in plain language. This second could be either an accompanying document that amplifies the contents of the guidance or a plain language version of the guidance. In either case, FDA will then have to develop a means of getting the appropriate document into the hands of the right people. This task may be difficult, and the best approach is not at this point apparent to us. Specific Comments Our specific comments, which generally seek greater clarification, are presented in the attached table. Thank you again for the opportunity to provide input into this important document. If you have questions or would like additional information please contact me at bliebler@advamed.org or Sincerely, Bernie Liebler Director, Technology & Regulatory Affairs

3 AdvaMed Comments Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed Entire Document General Draft a separate, updated guidance document on software applications as medical devices. Remove references in the Mobile Applications document to applications that are purely software tools (i.e., MDDS, data analysis, trending, calculations of indices, etc.) Focus the Mobile Applications Guidance on Apps that control other devices or turn a mobile platform into a medical device. AdvaMed General There are no instructions in the new guidance regarding the classification for bidirectional electronic health records/applications AdvaMed General As this is the first statement of FDA regulation as it applies to mobile apps, we recommend FDA exercise enforcement discretion for mobile apps that have been previously released without FDA clearance/approval, but that meet the definition of mobile medical application under the new guidance for a specified period of time to allow manufacturers to submit the necessary application from the date of the final guidance. AdvaMed 227 ff. FDA should include greater delineation of the difference between a mobile app for general health and wellness vs. one for the treatment. As we learn the effect of diet, exercise, and sleep, it can be hard to draw the line between something that is FDA regulated and something that is not, AdvaMed 108 In the definition of mobile platform, clarify tablet computer refers to any laptop with a touch screen, even if the laptop also includes a traditional keyboard AdvaMed a mobile application or "mobile app" is defined as a software application that can be executed (run) on a mobile platform or personal computer, or a web-based software application that is tailored to a mobile platform but is executed on a server Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Mobile applications that are purely software tools will potentially have multiple, redundant pathways to clearance that can cloud the regulatory space. By releasing a further updated Software guidance, these tools can be called out under the same framework as other software devices. The FDA did not look at clinical decision support systems or bidirectional electronic health records, with which you can input data into the record. Define more accurately, the difference between regulated and nonregulated applications. There is no clear definition of the classification of an ipad running a diagnostic app. After tablet computer insert,,including touch screen laptop with or without a traditional keyboard, -Add personal computer to the definition of Mobile Application, since many applications can be run solely from a PC without a mobile device.

4 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed 153 Technical It is not clear whether an MMA developer who allows users to access the application s medical device functionality over its web for free (no download) is considered a medical device manufacturer. In this case, he is not manufacturing or selling any thing, therefore not introducing any thing into interstate commerce. There are really two questions here for the purpose of determining whether something is subject to the regulation or not. First, is there any difference between providing a medical device and providing a medical service? We believe FDA regulates only medical devices, not medical services. In the example provided, we believe the provider is not providing a device; at most only a service. Therefore, he should not be subject to the medical device regulations. Second, when an MMA is promoted not for obvious commercial purpose (in the example provided, let s say the provider uses the MMA to promote his medical educational webpage), how do we draw the line? We recommend FDA provides more clarity, especially with regard to situations where no specific product is sold or promoted for commercial purposes. AdvaMed General The definition of developer is understood. It is also our understanding that when development is outsourced due to greater skill sets of outside developers, then the manufacturer would be bound by the Supplier quality requirements. AdvaMed For additional guidance provide explanatory text with each of the examples of mobile apps that FDA does not consider mobile medical apps as it relates to those that do not meet the definition of device and those that are medical devices, but not mobile medical apps. This additional information will provide stakeholders with guidance for assessing other applications not specifically listed as an example. AdvaMed 193/294 General Would like the FDA to clarify its position on inclusion or exclusion of routine administrative collection of Clinical data. Based upon the perceived intent of the guidance, collection of Clinical Data should be specifically excluded from the definition of Mobile Medical Applications. Include a reference to the Supplier quality requirements 21 CFR on top of the design control requirements of Mobile device applications used for the routine collection of Clinical Data to support studies or for use as an input to other regulated processes via a mobile device are not considered a Mobile Medical Application. 2

5 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed 193/246 General Would like the FDA to clarify its position on inclusion or exclusion of using a mobile app in support of production process data and quality system data/record management. Based upon the perceived intent of the guidance, such data should be specifically excluded from the definition of Mobile Medical Applications because they do not meet the definition of medical device in the FDCA. Mobile device applications used for the production process, other than custom device production, and/or quality system data collection (including complaint submissions) are not considered a Mobile Medical Application because they do not meet the definition of medical device. However, such applications are part of the quality system. As such, these applications need to adhere to the appropriate regulations (e.g., 21 CFR 211 and 820). AdvaMed 197 Provide additional instructional text regarding mobile apps that are electronic copies of medical textbooks, teaching aids, or references, or solely used to provide clinicians with training or reinforce training previously received which states these items are not mobile medical apps because they do not meet the definition of medical device under the FDCA. These categories are typically not regulated medical devices in their traditional forms. For example, medical textbooks are not regulated as medical devices, so simply presenting medical textbooks in the form of a mobile application would not cause the material to meet the definition of a medical device. To the end of the first sentence (line 197) insert are not considered mobile medical apps, provided these apps do not contain patientspecific information, because they do not meet the definition of medical device in the Food, Drug & Cosmetic Act. After the revised first sentence, insert the following: These categories are typically not regulated medical devices in their traditional forms. For example, medical textbooks are not regulated as medical devices, so simply presenting medical textbooks in the form of a mobile application does not meet cause the material to meet the definition of a medical device. AdvaMed For additional guidance provide explanatory text with each of the examples of mobile apps that FDA does not consider mobile medical apps as it relates to those that do not meet the definition of device and those that are medical devices, but not mobile medical apps. This additional information will provide stakeholders with guidance for assessing other applications not specifically listed as an example. AdvaMed For additional guidance provide explanatory text with each of the examples of mobile apps that FDA does not consider mobile medical apps as it relates to those that do not meet the definition of device and those that are medical devices, but not mobile medical apps. This additional information will provide stakeholders with guidance for assessing other applications not specifically listed as an example. AdvaMed 221 General Need clarification on how one might view an application that was not intended to be a medical application, but was used as such, assembled to be such, or a component of such. Revise the first two sentences to read: Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness are not mobile medical apps because they do not meet the definition of medical device in the Food, Drug and Cosmetic Act because these apps do not provide decisions, suggestions, or recommendations intended for curing, treating, seeking treatment for mitigating or diagnosing a specific disease, disorder, patient state, or any specific identifiable health condition. At the end of the first sentence insert: because these mobile apps do not meet the definition of medical device in the Food, Drug and Cosmetic Act. Suggest using wording consistent to that of the MDDS guidance. 3

6 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed General Mobile apps not regulated (see lines ) Mobile apps that perform the functions of an electronic health record Clarify which functions will be regulated and which will not be. Do not lump functionality under EHR/PHR systems. system or Personal Health Record system. Guidance goes on to state that FDA will apply regulatory oversight to: (see lines ,416, ). These lines describe functionality common within EHRs and PHRs. AdvaMed 311 Clarification ADD: Mobile platforms that support such mobile medical apps are not considered regulated medical devices. AdvaMed Footnote 12 referenced at line 241 Text of footnote contained in Lines of numbered lined version of guidance. We recommend FDA more clearly elucidate the types of applications that would be subject to enforcement discretion so manufacturers can better understand when a mobile app would be regulated. Specifically, we recommend clarification in the following areas: Delete automate common medical knowledge available in the medical literature as this appears to apply to electronic copies of text books, reference materials, etc., which would not meet the definition of medical device, and therefore enforcement discretion is not necessary. If this is not what is intended by this statement, we recommend further clarification to distinguish these types of mobile apps from those that are electronic copies. Clarify that mobile apps that simply replace a pencil and paper log for tracking or storing information, such as doctor visits, calories consumed, weight, are not medical devices provided the app does not manipulate the data through an algorithm or provide decisions, suggestions, or recommendations intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. From the presented examples, the statement that lead to appears to be a critical element of the assessment process. It appears that functionality beyond simply logging and storing information is a distinguishing factor in determining whether an app is a mobile medical app subject to FDA enforcement discretion. We recommend further elucidation and/or clarification of this aspect to provide manufacturers with more guidance. 4

7 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed Text of footnote 12 contained in Lines of numbered lined version of guidance. Provide additional examples of mobile app functionality that is subject to FDA enforcement discretion. Insert: Mobile apps that log or track data and include functionality that leads to electronically (e.g., ) reporting information to a health care professional is example of a mobile app subject to enforcement discretion. 5

8 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed This is speculative and offers no additional guidance for application development. The ultimate message of this Remove the following: The FDA plans to address in a separate issuance mobile medical apps intended to analyze, process, or interpret medical paragraph is that analysis tools may add addition device data (electronically collected or manually entered) from more than one medical device. The implications of these analyses and interpretations functionality or risk beyond that of the associated medical may pose a wide range of risks to public health and patient safety. Requiring device and may thus require reclassification and/or different such mobile medical apps to comply with the same requirements as their pathways to market. Follow on question to this paragraph connected devices may not be appropriate in some cases. For example, would be: What are the regulatory implications of a mobile analysis of class I device information along with other demographic application whose classification is beyond that of its associated device? Does this in fact change the classification of the App Device system and ultimate the information can result in an interpretation of a highly acute patient condition, which presents a greater risk than the connected class I device. On the other hand, an analysis or interpretation of data from class II or class III devices associated device itself? can lead to a simple informational result, with minimal implications or risks to public health and patient safety in other words, a level of risk more characteristic of a class I device. The FDA has previously classified software that calculates a drug dose based on a patients height, weight, mass, and other patient-specific information as a "Drug Dose Calculator" under 21 CFR AdvaMed What is the process / procedure for this discussion and how will both the developer/manufacturer and the Agency be held to the conclusions drawn from it? Or change to: Mobile medical apps intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device may pose a wide range of risks to public health and patient safety. Requiring such mobile medical apps to comply with the same requirements as their connected devices may not be appropriate in some cases. For example, analysis of class I device information along with other demographic information can result in an interpretation of a highly acute patient condition, which presents a greater risk than the connected class I device. On the other hand, an analysis or interpretation of data from class II or class III devices can lead to a simple informational result, with minimal implications or risks to public health and patient safety in other words, a level of risk more characteristic of a class I device. Such applications require detailed analysis of any additional safety or efficacy risks that can arise from the analyses and interpretations of the data on the mobile application to determine device classification and pathway to market The FDA encourages manufacturers of such mobile medical apps to contact the Agency to determine the classification of their mobile app. Add mechanism for this discussion. 6

9 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed 395 We recommend FDA further clarify its expectations for mobile medical app distributors in terms of their cooperation in conducting corrections and removals. Insert: Mobile medical app distributors should be required to timely assist manufacturers in executing correction or removal actions and should be required to provide information to help manufacturers identify who has downloaded a mobile medical app, when necessary, to enable product recalls, repairs, replacement or look back. AdvaMed 407 General Pan and zoom can hardly be considered a processing function that would make an application a medical device. This functionality would be the same as a human viewing different parts of an image or looking more closely at an image. The other functionality mentioned would be similar to turning over those activities to the software to improve accuracy or improve upon human-only activity. AdvaMed General Canadian authorities determined that the calculations in one company s software product to log dose chemotherapy does not treat patients or use novel measurements/calculations used for patient diagnosis. The calculations that they use are industry standard algorithms e.g. BMI, dose calculations. These calculations can be done using a simple calculator and paper, and are found in industry standards or textbooks. These functions do not relate to treatment or diagnosis. This appears similar to the use of computers in a similar manner as a typewriter, which I believe was FDA s rationale on deciding when to validate computers for Quality System compliance. AdvaMed General Stakeholders are directed to the searchable medical device classifications database. Specifically state pan and zoom in lines as a function of generic aids as well as a device software application function in lines Ensure harmonization with the Canadian authorities the difference between patient-specific developed algorithms and standard algorithms. i.e. apply the typewriter example for computer validation in comparison to generic aids in lines (or in general under lines ). i.e. non-standard algorithms would be classified as the examples under lines We recommend providing a mechanism to search FDA medical device databases for applications specific to mobile apps, such as through the term mobile app, unique product code, or other mechanism. 7

10 Date Document 19 October 2011 FDA Draft Guidance on Mobile Apps Commenter Line No. Type of COMMENTS Proposed Language comment Reason for Change on each comment submitted (General/ Technical) AdvaMed 557 Technical This statement could be interpreted as meaning the FDA is somewhat permissive in allowing configuration control for mobile medical applications platforms to be limited to what can be specified through purchasing, whereas the platform hardware and/or software may be changed at a lower level than what can be reasonably verified. It would be helpful to clarify if this is the intent. Additionally, this could be applied beyond purchasing and into labelling/instructions for use. Purchasing controls related to the underlying hardware and its components shall be based upon appropriate supplier evaluations, and where appropriate, application inspections and validations. The level of inspection and validation shall be based upon the risk associated with the application. AdvaMed 557 Technical The guidance avoids the mobile medical application manufacturer s responsibilities to adequately limit the use of an application based upon make and model number, including components of a hardware platform that may affect the operation of the application. Specifically, an application may not function properly based upon the hardware upon which it is installed. This may also include firmware that is resident on such hardware. The guidance needs to outline to what extent the application manufacturer needs to explicitly restrict use. AdvaMed 632 Technical Multiple URLs for the guidance documents are incorrect. AdvaMed 699 Technical We recommend that FDA remove from the Footnote 5 any reference to the determination of intended used based on actual use or manufacturer s knowledge of actual use, as well as the associated language regarding manufacturer s labeling responsibility. Also, we believe FDA should consistently apply the same principle of regulatory policy (not to determine intended use based on actual use) throughout the spectrum of the regulated devices (e.g., MMA, RUO/IUO devices, etc.). The extent to which the manufacturer shall validate and appropriately label/indicate the installation of the application on user owned hardware/equipment shall be dependent upon the risk associated with that application. 8

11 Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications DRAFT GUIDANCE Document Issued on: July 21, 2011 This guidance document is being distributed for comment purposes only. You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD Submit electronic comments to Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this document, contact Bakul Patel at or by electronic mail at Bakul.Patel@fda.hhs.gov. For questions regarding this document concerning devices regulated by CBER, contact the Office of Communication, Outreach and Development (OCOD), by calling or U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research 17 Preface Additional Copies CDRH Additional copies are available from the Internet. You may also send an request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to to receive a hard copy. Please use the document number (1741) to identify the guidance you are requesting. CBER Additional copies of this draft guidance are available from the Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD , or by

12 calling or , or from the Internet at Table of Contents I. INTRODUCTION II. BACKGROUND III. DEFINITIONS A. MOBILE PLATFORM B. MOBILE APPLICATION (MOBILE APP) C. MOBILE MEDICAL APPLICATION (MOBILE MEDICAL APP) D. REGULATED MEDICAL DEVICE E. MOBILE MEDICAL APP MANUFACTURER IV. SCOPE V. REGULATORY APPROACH FOR MOBILE MEDICAL APPS A. MOBILE MEDICAL APPS FOR WHICH FDA WILL APPLY REGULATORY OVERSIGHT VI. REGULATORY REQUIREMENTS A. REQUIREMENTS FOR MOBILE MEDICAL DEVICE MANUFACTURERS SUBJECT TO REGULATORY OVERSIGHT B. EXPECTATIONS FOR MOBILE MEDICAL APP DISTRIBUTORS APPENDIX A - EXAMPLES OF MOBILE MEDICAL APPS APPENDIX B - EXAMPLES OF CURRENT REGULATIONS APPENDIX C - BRIEF DESCRIPTION OF REGULATORY REQUIREMENTS APPENDIX D - ADDITIONAL RESOURCES Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications This draft guidance when finalized will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance I. Introduction The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps"). Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time,

13 the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps." FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required. II. FDA Regulation of Research Use Only and Investigational Use Only IVD products A growing number of software applications are being developed for use on mobile platforms, which include smart phones, tablet computers, and personal digital assistants. As these mobile platforms become more user friendly, computationally powerful, and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care. In 1989, FDA prepared a general policy statement on how it planned to determine whether a computerbased product and/or software-based product is a device, and, if so, how the FDA intended to regulate it. The document, "FDA Policy for the Regulation of Computer Products, became known as the "Draft Software Policy." After 1989, however, the use of computer and software products as medical devices grew exponentially and the types of products diversified and grew more complex (and that trend has continued). As a result, the FDA determined that it would be impractical to prepare an overarching software policy to address all of the issues related to the regulation of all medical devices containing software. Therefore, the Draft Software Policy was withdrawn. 1 Although the FDA has not issued an overarching software policy, the Agency has formally classified certain types of software applications that meet the definition of a device and, through classification, identified specific regulatory requirements that apply to these devices and their manufacturers. These software devices include products that feature one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems). On February 15, 2011, the FDA issued a regulation down-classifying certain computer- or software-based devices intended to be used for the electronic transfer, storage, display, and/or format conversion of medical device data called Medical Device Data Systems (MDDSs) from Class III (high-risk) to Class I (low-risk). 2 Moreover, the FDA has previously clarified that when standalone software is used to analyze medical device data, it has traditionally been regulated as an accessory to a medical device 3 or as medical device software. As is the case with traditional medical devices, mobile medical apps can pose potential risks to public health. Moreover, mobile medical apps may pose additional or different risks due to the unique characteristics of the platform. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform; FDA intends to take these limitations into account in assessing the appropriate regulatory oversight for these products.

14 This guidance clarifies and outlines the FDA's current thinking. The Agency will continue to evaluate the potential impact these technologies might have on improving health care, reducing potential medical mistakes, and protecting patients. III. Definitions A. Mobile Platform For purposes of this guidance, "mobile platforms" are defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. Examples of these mobile platforms include mobile computers such as the iphone, BlackBerry phones, Android phones, tablet computers, or other computers that are typically used as smart phones or personal digital assistants (PDAs). B. Mobile Application (Mobile App) For purposes of this guidance, a mobile application or "mobile app" is defined as a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server. C. Mobile Medical Application (Mobile Medical App) For purposes of this guidance, a "mobile medical app" is a mobile app that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 4 ; and either: is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device. The intended use of a mobile app determines whether it meets the definition of a "device." As stated in 21 CFR 801.4, 5 intended use may be shown by labeling 6 claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device. One example is a light emitting diode (LED) included on a mobile platform with a mobile app to make that LED operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific device intended use), neither the mobile app nor the mobile platform would be considered medical devices. If, however, through marketing and distribution, the mobile app is promoted by the manufacturer for use as a light source to examine patients, then the mobile app would meet the definition of a device. (In this case, the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.) In general, if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. For example, mobile apps intended to run on smart phones to analyze glucose meter readings would be considered similar to software running on a desktop computer, which is regulated under 21 CFR ("glucose test system"). D. Regulated Medical Device

15 For purposes of this guidance, a "regulated medical device" is defined as a product that meets the definition of "device" in section 201(h) of the FD&C Act and that has been classified by the FDA, or otherwise approved or cleared by the FDA review of a premarket application or other submission for the device. Examples of such devices are identified in Appendix B. E. Mobile Medical App Manufacturer For purposes of this guidance, a "mobile medical app manufacturer" is defined as any person or entity that manufactures mobile medical apps in accordance with 21 CFR Parts 803, 806, and This term does not include entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions; examples of such distributors may include owners and operators of "android market", "itunes store", and "BlackBerry App World." A mobile medical device manufacturer may include anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. Examples of mobile medical device manufacturers include any person or entity that: Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a software system from multiple components. This could include a person or entity that creates a mobile medical app by using commercial off the shelf (COTS) software components and markets the product to perform as a mobile medical app; Provides mobile medical app functionality through a "web service" or "web support" for use on a mobile platform. For example, a manufacturer of a mobile medical app that allows users to access the application's medical device functionality over the web is considered a mobile medical app manufacturer; Initiates specifications or requirements for mobile medical apps or procures product development/manufacturing services from other individuals or entities (second party) for subsequent commercial distribution. For example, when a "developer" (i.e., an entity that provides engineering, design, and development services) creates a mobile medical app from the specifications that were initiated by the "author," the "author" who initiated and developed specifications for the mobile medical app is considered a "manufacturer" of the mobile medical app under 21 CFR For purposes of this guidance, manufacturers of a mobile medical app would include persons or entities who are the creators of the original idea (initial specifications) for a mobile medical app, unless another entity assumes all responsibility for manufacturing and distributing the mobile medical app, in which case that other entity would be the "manufacturer." 8 Software "developers" of a mobile medical app that are only responsible for performing design and development activities to transform the author's specifications into a mobile medical app would not constitute manufacturers, and instead the author would be considered the manufacturer; or Creates a mobile medical app intended to be used on a mobile platform, or that manufactures a mobile app to be supported by hardware attachments to the mobile platform with a device intended use. For purposes of this guidance, a mobile platform manufacturer that commercially markets a mobile platform with an intended use (as defined in 21 CFR 801.4) of, or to be used with, a device is considered a device manufacturer under 21 CFR 803, 806 and 807. In contrast, a mobile platform manufacturer that solely distributes or markets its platform with no device intended use is considered a component 9 manufacturer and is exempt from quality systems, registration and listing requirements as described in those regulations. 10 In other words, the fact that a mobile platform could be used to run a mobile medical app identified by this guidance does not mean that the mobile platform manufacturer is considered a medical device manufacturer. For example, if it is possible to run mobile medical apps on

16 BrandNamePhone but BrandNamePhone is not marketed by BrandNameCompany with a medical device intended use, then BrandNameCompany would not be a medical device manufacturer. IV. Scope This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III, includes only those that meet the statutory definition of a device; and either: are used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device. This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s). This guidance is limited only to mobile medical apps. The following examples represent mobile apps that FDA does not consider to be mobile medical apps for purposes of this guidance: Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received. These types of apps do not contain any patient-specific information, but could show examples for a specific medical specialty. Examples of such medical text books include the electronic Physician's Desk Reference and similar reference materials that are typically used as part of course instruction and are implemented as electronic books. Exemplary teaching aids and reference materials include: flash cards or quizzes that are used for training purposes or as reference material (e.g., with preloaded medical images, conditions, pictures, graphs, etc.); slideshows of common conditions; lists of medical terminology; and review materials that are to be used by medical students during training. (In contrast, mobile apps that allow the user to input patient-specific information along with reference material to automatically diagnose a disease or condition are considered mobile medical apps). Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness. Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions. Examples include: apps that determine billing codes like ICD-9 (international statistical classification of diseases); medical business accounting functions and aids that track and trend billable hours, procedures, and reminders for scheduled medical appointments or blood donation appointments; apps that automate functions such as collecting patient histories that replace paper-based entry; apps that enable insurance claims data collection and processing; and other apps that are similarly administrative in nature. Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication. Examples include apps that use the mobile platform as a magnifying glass (but not specifically for medical purposes), 11 recording audio, note-taking, replaying audio with amplification, and other similar functionalities.

17 Mobile apps that perform the functionality of an electronic health record system or personal health record system. V. Regulatory approach for mobile medical apps The FDA recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and potential benefits and risks to public health. Some manufacturers of mobile medical apps have sought premarket clearance for their devices; however, many may be unsure about how the FDA regulations apply to their products. As described in this guidance, the FDA plans to apply its regulatory oversight only to certain types of mobile apps. This narrowly-tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device. The FDA believes that this subset of mobile apps poses the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended. Using mobile or other innovative platforms along with a mobile medical app to perform medical device functions does not necessarily change the intended use or the risk to patients if the device fails to operate properly. Although some mobile apps that do not meet the definition of a mobile medical app may meet the FD&C Act's definition of a device, FDA intends to exercise enforcement discretion 12 towards those mobile apps. The FDA intends to monitor the performance of other 13 mobile apps that are outside this guidance and determine whether additional or different actions are necessary to protect the public health. A manufacturer may, however, at its discretion, elect to register and list, and to seek approval or clearance for these mobile apps with the FDA. Nevertheless, the FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality Systems 14 regulations (which include good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm. The FDA has found that the majority of software-related device failures are due to design errors. In one study, the most common problem was failure to validate software prior to routine maintenance. 15 For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. A mobile medical app, like other devices, may be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval). 16 The FDA has typically expected that the manufacturer of an accessory would meet the requirements associated with the classification of the connected device. However, this approach may not be well-suited for mobile medical apps that serve as an accessory to another medical device because of the wide variety of functions mobile medical apps can potentially perform. Therefore, FDA is seeking comment on how it should approach mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured. Mobile medical devices that are intended to be used as accessories to a regulated medical device may do so for purposes of (a) displaying, analyzing, storing, or transmitting patient-specific medical device data, or (b) controlling the operation, function, or energy source of the medical device (see Appendix A for examples).

18 Finally, if the mobile medical app adds medical device functionality to a mobile platform, the mobile medical app manufacturer must meet the classification requirements applicable to that functionality. A. Mobile medical apps for which FDA will apply regulatory oversight Mobile apps may take a number of forms, but it is important to note that the FDA will apply its regulatory oversight to only the subset of mobile medical apps as expressed in this guidance. Similarly, mobile medical apps that transform a mobile platform into a regulated medical device may do so by using attachments, display screens, sensors, or other such methods (see Appendix A for examples). The following examples represent mobile apps FDA considers mobile medical apps and that will be subject to its regulatory oversight: Mobile apps that are an extension of one or more medical device(s) by connecting 17 to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient-specific medical device data include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform. Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples include a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea. Mobile apps that allow the user to input patient-specific information and - using formulae or processing algorithms - output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient. To further clarify, the following categories identify the types of mobile medical apps and their associated classifications. Displaying, storing or transmitting patient-specific medical device datain its original format Mobile medical apps with this functionality constitute an MDDS (21 CFR ) and are subject to class I requirements (general controls), which include adequate design controls, registration, device listing, adverse event reporting, and corrections and removals. The FDA believes that requiring general controls sufficiently manage the risks for mobile medical apps that are used as a secondary display to a regulated medical device and are not intended for providing